Job Description:
If you are an expert in software used to design, build or control the manufacturing of medical devices and you well understand the regulatory affairs related to such software, and are looking for an affiliate contract role with plenty of variety, to share your knowledge and experience with others, this role may be for you.
Location: Remote - USA, Canada, UK, Ireland, EU
Hiring Company: Oriel STAT A MATRIX ( Website )
Founded in 1968, Oriel STAT A MATRIX is a leading global organization providing consulting and training services to the regulatory affairs and quality assurance functions within the life sciences industry. We are proud of our focus on client outcomes: We achieve superior client results because we select from a pool of highly skilled, specialized, commercially minded quality system and regulatory affairs employees and a set of affiliate consultants with exceptional skills in specific areas. Together, our team executes best-in-class advisory, audit, consulting, and training services in the life sciences market. We are looking for individuals who possess a level of skills, attributes, and talents commensurate with our brand.
Our Affiliate Non-Product Software Validation RA/QA Instructor role is for independent contractors who are home-based and are able to travel to client sites for delivery or are able to deliver through virtual technology. We therefore seek highly organized individuals who are self-starters, good communicators, and open to flexible work arrangements, seeking variety in the work they do.
Position Description
The Affiliate Non-Product Software Validation RA/QA Instructor is responsible for planning and delivering software validation training in the life science industry, including insights into the aspects of auditing and quality related to RA/QA infrastructure. In particular, to focus on the process of evaluating and controlling system and user requirements to insure they meet intended use of the product. Transfer essential skills regarding validation of processes for production and services and for the control and monitoring of production equipment. Position holders may also be offered the chance to contribute to the development of training-related intellectual property.
Person Description

• Has been in an independent consulting capacity for at least two years
• Has a confident personality and is competent in getting ideas across to others effectively
• Demonstrates an ability to work in a team environment, especially when operating remotely
• Displays a passion for patient safety through effective quality assurance and audit activities
• Respects the contributions of all colleagues and facilitates consensus on tough issues
• Demonstrates flexibility in day-to-day working with the team and in their approach to unique client issues
• Has the ability to assimilate diverse data, think critically, and solve problems
• Is committed to continual learning and maintaining professional standing

Basic Qualifications

• Bachelors degree in an appropriate software engineering-related field; Masters degree preferred
• Evidence of progressively taking more responsibility and leading wider activities in the medical devices industry
• Direct experience with software planning, design and control, compliance, inspections, and quality systems
• A minimum of 7 years leading life sciences and/or RA/QA-related projects covering a wide range of intended uses
• Outstanding ability to think critically, solve problems, and learn new concepts and activities
• Thorough knowledge of regulatory pathways for drug development, registration, and post-approval

Industry Requirements

• Has experience with:
• Life sciences software development and interpretation and application of codes, regulations, and standards (cGMP, 21 CFR Part 820, etc.)
• Quality systems planning and implementation, design control, and process validation
• US FDA, Health Canada, and/or relevant UK / EU regulations
• Software development life cycles and cybersecurity activities a plus

Travel
Ability to travel extensively domestically (30%-50% of the time). Occasional international travel may be required.
Required Skills:
•Hiring
•Validation
•Manufacturing
•Software
•Design

Salary Package:
$ 120.00 - 165.00 (US Dollar)